Devices, methods and applications for intelligent medical packaging

ABSTRACT

An intelligent package system for holding or delivering medical pharmaceuticals, controlled substances, or hazardous materials includes at least one integral active display, a controller and one or more of the following: a programmable memory; one or more sensors; a communication interface device; a power source; one or more user input devices; and an externally connected device in communication with the controller/display. The active display allows static as well as dynamic visual information to be presented, and may be printed or stamped directly onto the surface of the pharmaceutical container or packaging to provide for enhanced information display, access, and visibility.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application Ser.No. 60/715,692, filed on Sep. 9, 2005, the contents of which areincorporated herein by reference.

BACKGROUND OF THE INVENTION

This invention relates to medical containers and, more particularly, toactive displays or labels for use with medical containers to allowstatic and/or dynamic information to be provided visually to usersthereof.

There are many types of containers used to store and deliver medicalpharmaceuticals. Some examples include contrast agents used for medicalimaging procedures, blood, plasma, parenteral feeding solutions, lipidsolutions, re-hydration fluids, such as ringers-lactate solution, andspecial therapeutic drugs. These containers may include bags, bottles,syringes, or other custom packages or delivery containers. Many of thesecontainers contain printed, attached, or embedded labels based on paperor foil materials, however, these labels have many limitations.

For example, current label technology is static and inflexible—only afixed and limited amount of information may be displayed. Static labelshave limited space for information; so many pharmaceuticals must bepackaged with a separate package insert containing instructions ondosing, indications for use, contraindications, potential side effects,and other important information. These package inserts may be lost, ifthey are not attached to the container. Small print makes these labelsdifficult to read, especially in low light conditions and for those withvisual impairment. Any changes to the information on the pharmaceuticalcontainer or package insert require new printing. In addition,regulations require region or state specific language, increasing thenumber of label types that must be provided, or increasing the lengthand complexity of the package or package insert. For example, manypharmaceutical packages have label pullouts or label fanfolds arerequired, adding cost and complexity. The technology used with thesecontainers and package inserts are easily counterfeited, providinglittle protection of product authenticity or integrity. Finally, complexlabels and package inserts are not well suited for gaining the operatorsattention, due to the volume and complexity of the information containedwithin a small space.

SUMMARY OF THE INVENTION

Containers, packages, or delivery systems and instruments with activedisplays may provide many benefits. An active display allows static aswell as dynamic visual information to be presented. Polymer LED andOrganic LED technologies may be suitable for these active displays.Polymer light emitting display (PLED) technology is a relatively recent,low power, low cost, easy to manufacture flexible display technology.PLED technology is also sometimes referred to as “organic displaytechnology” or “OLED technology”. This display technology may be coupledwith pharmaceutical packages and containers to provide an integralinformation display. Integral displays may be printed or stampeddirectly onto the surface of the pharmaceutical container or packagingto provide for enhanced information display, access, and visibility.

In one aspect, the present invention provides a stand-alone intelligentpackage system for medical, pharmaceutical or hazardous materialapplications, including at least one integral active display.

In another aspect, the present invention provides a method for using apharmaceutical or a controlled or hazardous materials container with anincorporated display includes the presentation of operator instructions,indications for use, cautions or warnings to one or more users.

In another aspect, the present invention provides a method for using apharmaceutical container with an incorporated display. The display isactivated through operator input, a sensor input condition at someperiodic time interval, or by connection to or from an associateddevice.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a syringe having a printed polymer light emittingdisplay on the outer surface of the syringe barrel.

FIG. 2 illustrates a syringe having a self-powered display similar tothat in FIG. 1.

FIG. 3 illustrates a foil covered pharmaceutical container with anintegral display.

FIG. 4 illustrates a bag container with an integral display.

FIG. 5 illustrates a pharmaceutical bottle container with an integraldisplay.

FIG. 6 illustrates a multiple-in-line syringe (MILS) pump.

FIG. 7 illustrates a container with a display and an associated devicewithin an operating environment.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION

Polymer light emitting displays emit light when provided with electricalenergy. A display consists of polymer material manufactured on asubstrate of glass or plastic. Polymers are chemical substances thatconsist of large molecules that are, themselves, made from many smallerand simpler molecules. Most of these types of displays do not requireadditional components such as filters and polarizers. The displaytechnology is very energy efficient, visible in bright ambient light,and may be manufactured in thin form factors that will operate with lowvoltages. These displays also have a very wide viewing angle and highcontrast, which are limitations of several other display technologies.Polymer light emitting displays may be constructed for monochrome orcolor operation with an operating life of 10,000 to 20,000 hours undertypical operating conditions. They also have very fast switching speeds(up to 1000 times faster than LCDs) and so may be used for dynamicdisplay applications, such as video display. Polymer light emittingdisplays are constructed by placing an amorphous semi-conducting polymerfilm, such as polyvinylcarbazol (PVK), or polyparaphenylene, typicallyless than 100 nm thick, between two metallic electrodes forming an anodeand cathode on a transparent substrate. Transparent electrodes arecommonly made of indium tin oxide (ITO), 0.1 to 0.3 mm thick, aluminum,or other thin conductive transparent material. ITO is typically used forthe anode and aluminum for the cathode, though ITO may be used for both.Charges are injected into the polymer from the electrodes; recombinationof charges within the substrate of the electron-hole pairs generateslight. The wavelength of the emitted light depends on the particularband gap of the polymer used, the color of the substrate, and anyembedded dyes. An almost infinite color range within the visible and IRspectrum is possible. The entire assembly is typically printed or placedonto a glass or polyethyleneterephthalate (PET) surface as a substrate.Polymer light emitting displays may be used with active or passivematrix configurations, depending on the size and performance needed.

Displays may be constructed using ink-jet printing, stamp printing, spincoating, or screen-printing methods for depositing the polymer andconductive films onto the substrate. Also, because of the relatively lowmanufacturing and materials costs for these displays, they are wellsuited to disposable use, a common requirement for maintainingpatient-to-patient sterility with medical devices and packages.

The drawing in FIG. 1 illustrates a syringe 2 with a printed polymerlight emitting display 100 on the outer surface 20 of the syringe barrel22. Attached to and beneath the display 100 are printed conductors 101,which carry electrical power and communication signals to the displayfrom the attached injector system (not shown). The syringe 2 istypically made of glass or molded plastic material such aspolypropylene, polyethylene, polycarbonate or PET. When the syringe 2 isattached to the injector system, power is provided and the display 100is able to show information. In this example, the display 100 containsan operator message to instruct them to check for air in the syringe 2,as well as information on the contents and status of the material insidethe syringe 2.

As an alternative configuration, the display 100 may be used as anillumination device for a package to identify the materials within or toprovide light for reading traditional printed labels. For example, itmay be useful in some medical applications to illuminate the interiorcontents of the syringe 2 or delivery container to verify the contentsor that the container is completely filled with the correct amount andtype of fluid or drug. As another example, some drugs may requireoptical or infrared illumination for activation or fluid assurance.Infrared illumination may be used to warm or heat contents of thecontainer. In addition, illumination may be used to excite or causefluorescence of the contents to identify verify the contents of thecontainer (i.e. IR fluoroscopy or spectroscopy).

This technology is especially suited for illumination applications whereit is difficult to apply a standard light source or method, such asincandescent, fluorescent, LED, or other source, due to volume or space,or form factor limitations. This technology is also suitable for lowpower, low cost, low voltage applications, as common with hand-held,portable, or disposable instruments and containers. The technology mayalso be used to provide illumination or active labeling for invasive andnon-invasive medical instruments, for example, illumination associatedwith endoscope or laparoscopy instruments.

The drawing in FIG. 2 illustrates a syringe 2 with a display 200,similar to that described in FIG. 1. In this case there are no powersignals to the syringe 2 from the attached injector system as thedisplay 200 is self-powered and communication with the display 200 isperformed in a wireless fashion.

The drawing in FIG. 3 illustrates a foil covered pharmaceuticalcontainer 3 with an integral display 300. In this case the container 3is a foil bag containing a pharmaceutical solution. The display 300 alsocontains a printed battery 310 as a power source, shown on the lowerdarkened portion of the display area. The display 300 indicates thecontents and status of the bag 3, as well as the time expired sinceopening. When the time since opening exceeds a predetermined limit, thebag 3 must be replaced or removed. Note that removing a protective cover320 from the display surface 330 or removing a pull-tab is used toactivate the display 300. Note that it is also possible to activate thedisplay 300 by some other switch mechanism, such as a printed overlaybutton on the display area itself or elsewhere on the container.

In addition it is possible to couple the use of the active display withsensors to indicate delivery parameters, such as flow rate, temperature,pressure, conductivity, or other physical measurement. For example, itmay be useful for an IV solution bag to contain an integral flow ratesensor or volume level sensor that provides data, which may be shown onthe active display. This information may be communicated to the deviceby a wired or a wireless system.

The drawing in FIG. 4 illustrates a different container 4 with anintegral display 400. In this case the container 4 is a bag, such asthose used for holding pharmaceutical solutions such as saline,dextrose, feeding solutions, dialysis solutions, irrigation solutions,or specialty drugs in solution form. Typically, during manufacturing,bags are hot stamped in-line or in a separate step a label is appliedeither before or after the filling process. In this case, aself-contained flexible display 400 is printed onto the bag surface 14.The display 400 is activated in a similar manner to that described inFIG. 3.

The drawing in FIG. 5 illustrates a pharmaceutical bottle container 5with an integral display 500. Pharmaceutical bottles are typically madeof glass or plastic. The display 500 covers part of the outer surface 15of the bottle 5 and peels back so that more display 500 area isavailable. Peeling back the display 500 activates the display 500. Thedisplay 500 also contains embedded buttons 501 that may be used toselect what information is shown, including the language used.Information from the package insert for the pharmaceutical may be shownon the display 500 in a scrolling fashion so that a paper package insertis not required. Using printed electronics and a small amount ofelectronic memory, the display 500 can be used to show several pages ofinformation. Controls on the display 500 may be used to control the rateand direction of the information for the user.

The drawing in FIG. 6 illustrates a multiple in-line syringe (MILS)disposable pump 6 module. Displays 600 may be included on the surface ofthe module to show information related to the pump 6. For example, asmall display 600 on the device could indicate pump performanceparameters, operating time, or operating life remaining. Printeddisplays 600 may also be placed on other pump module configurations ordelivery path elements such as tubing and connectors and cartridgereservoirs.

The drawing in FIG. 7 illustrates a container 7 with a display 700 andan associated device within some operating environment. The container 7has a display 700 and controller, and may also have provisions foroperator input, memory, sensor devices, a power source, and an interfaceto other devices. These features may be implemented using conventionalor printed organic electronics placed on the surface of the container.Operator input may be from discrete switches, touch sensitiveelectrodes, or other mechanically activated switches, such as with apeel back protective membrane. Sensor devices may include sensors fortemperature, pressure, sterility, or other environmental factors. Theinterface may be wired, such as with a serial wired communication port,or wireless. For short-range communication, small printed antennas maybe used, as with RFID devices, to transmit and receive information fromthe display device. Coordination of the memory, display, interface,operator input, and sensors is performed by the display 700 andassociated controller.

The displays described and shown herein may be externally powered orself-powered using printed battery technology or some other internalpower source such as a solar cell. While the technology describedinvolves the use of emissive polymer light emitting displays, othertechnologies may be used that are transmissive or reflective. Single ormultiple displays may be placed on a container or package. In addition,displays may be automatically or manually activated, or activated whenattached to a connected system. Displays may be used to show static ordynamic information, such as video. In addition, displays may be placedon rigid or flexible compatible substrate surfaces. Also, containerswith displays may be disposable or reusable, depending on theapplication. Information to the display may be self-contained within thecontainer and display module or may be written to the display from aremote device in a wired or wireless fashion.

Active labels may be used to present large volumes of information, suchas for a pharmaceutical or drug package insert. When coupled with atouchpad, touch screen, or other switch or sensing technology, theinformation contained within the label may be quickly searched,scrolled, or accessed via an index or help function. This may be helpfulin a time sensitive or emergency situation. In addition, active labelsmay be designed such that when coupled with user input technology (i.e.a touchpad, touch screen, or other switch or sensing technology), theoperator may annotate, revise, add, delete, or otherwise edit thecontents as needed for their particular application.

Active labels on containers or packages may also be used foridentification and matching the pharmaceutical to the correct patient.For example, an active label on a container may display a bar codepattern so that existing tracking and inventory equipment may be used.In some hospitals, a barcode is placed on a pharmaceutical containerlabel that identifies the prescription, dose, and patient that themedication is for. This barcode label is read by the clinician andmatched to the barcode on the patient identification bracelet to confirmthat the two match. The barcode on the medication package may beprogrammed during preparation at the hospital pharmacy so that it may bedisplayed on the package when it is delivered for administration to thepatient. As an alternative, other patient identification information,such as patient name, social security number, hospital identificationnumber, photograph, or other unique biometric information may beprogrammed to be visible on the active package display so that theprescription may be matched to the patient. If biometric sensors areincluded on the package, such as a fingerprint scanner, the display maybe used to indicate when there is a correct match between the patientand the prescribed medication.

Note that the use of an active display and associated memory may providetamperproof security features for hazardous or controlled substances.Information may be permanently written and stored to the device at thetime of manufacture or when required. This provides an integral digital“watermark” that is associated with the package that providesauthentication of the product and user instructions. In addition, theuse of an active display may be used to indicate when a containercontains an “approved”, “prescribed”, or “sterilized” material or if itdoes not. The display may also be used to communicate information aboutproduct “freshness” or expiration time (“use by date”). Also, thisinformation may be a function of the product storage or operatingenvironment. For example, the “use by date” may be adjusted based onstorage temperature or other environmental conditions. In a differentembodiment the active display may be coupled with sensing devices suchas pressure sensors, gas sensors, chemical sensors, or tamper detectingswitches to indicate product tampering or mishandling. Caution andwarning messages may be displayed to indicate risks of using the productor deliver instructions for immediate disposal.

The use of an active display may also be used in conjunction with audiotransducers to provide sound as well as visual information. This allowspossible applications such as instructional videos, entertainment, andadvertisements to be included with the product container or package.These features may be useful for the hearing and site impaired.

Note that while the ideas described herein refer to oriented towardpharmaceuticals, drugs, and associated packaging, these ideas may beextended to labeling for other hazardous, regulated time sensitive,environmentally sensitive, or otherwise complex materials or products.For example, these ideas may be used for household chemicals,pesticides, agricultural materials and other consumer or industrialproducts where instructions for use may be long and complex.

The foregoing description and accompanying drawings set forth thepreferred embodiments of the invention at the present time. Variousmodifications, additions and alternative designs will, of course, becomeapparent to those skilled in the art in light of the foregoing teachingswithout departing from the scope of the disclosed invention. The scopeof the invention is indicated by the following claims rather than by theforegoing description. All changes and variations that come within themeaning and range of equivalency of the claims are to be embraced withintheir scope.

1. A stand-alone intelligent package system for medical, pharmaceuticalor hazardous material applications, includes: at least one integralactive display.
 2. The system of claim 1 where the display is on theouter or inner surface of the container.
 3. The system of claim 1wherein the display is printed, stamped, screened, embedded, orotherwise attached to the container.
 4. The system of claim 1 whereinthe display is placed as a label on the container or containerpackaging.
 5. The system of claim 1 wherein the display is constructedof organic light-emitting polymer material.
 6. A method for using apharmaceutical or a controlled or hazardous materials container with anincorporated display, comprising: presenting operator instructions,indications for use, cautions or warnings to one or more users thereof.7. The method of claim 6, further comprising: displaying informationabout the container, contents, or status thereof.
 8. The method of claim7 wherein the information includes dates or times regarding the contentsof the container.
 9. The method of claim 7 wherein the informationincludes manufacturing information, performance information orcalibration information.
 10. The method of claim 7 with the informationincludes status information regarding the contents of the container. 11.The method of claim 6, further comprising: displaying information fromthe device interface or a connected system.
 12. The method of claim 6,further comprising: displaying information from incorporated or separatesystems.
 13. The method of claim 12 wherein the information is one ormore of physical or temporal information.
 14. The method of claim 6,further comprising: display information based on a medication or anintended patient.
 15. The method of claim 14 wherein the information isone or more of prescribed dose, preparation instructions or patientidentification information.
 16. The method of claim 15 wherein thepatient identification information includes identification numbers,photographs or biometric data.
 17. The method of claim 14 wherein theinformation is one or more of contraindications, warnings or othersafety information.
 18. A method for using a pharmaceutical containerwith incorporated display, comprising: activating the display throughoperator input, a sensor input condition, at some periodic timeinterval, or by connection to or from an associated device.
 19. Themethod of claim 18 wherein the display has an internal memory that isprogrammed during the time of manufacture, filling, opening, use, ordisposal, with information to be displayed at a later time.
 20. Themethod of claim 18 wherein the display can be activated at least once.